In 2004, the United States Food and Drug Administration (FDA) transferred regulation of many highly purified, “well-characterized†biopharmaceutical proteins from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER), which until then had primarily regulated only synthetic, small-molecule drugs and chemical substances. The most novel/complex and the less-characterized biologics remained within CBER’s jurisdiction. This change complicated BPI’s mission somewhat. When the magazine was founded, we responded to questions from advertisers…
Economics
Small–Batch-Size Production
After coexisting as close cousins in the world of life sciences, the bioprocessing and cell therapy industries now find themselves as possible allies in the pursuit of solutions to small–batch-size production technology. As cell culture titers continue to increase and biotherapies become more “personalized,†pressure is increasing on the bioprocessing industry to find more cost-effective and flexible technologies for producing smaller batch sizes than before. At the same time, the cell therapy industry (renowned for its small–batch-size production)…
Upstream Single-Use Bioprocessing Systems
Single-use bioprocessing equipment has become well-accepted technology in a relatively short time. Disposable devices and components have created market niches and new segments that continue to evolve. In this dynamic environment, it is difficult to measure acceptance or assess market growth. Here we project the world market for cell culture single-use systems (SUS) as well as problems affecting that market, including adoption for commercial manufacture. This is based on our 10-year analysis of the industry, with data from our eighth…
Success Stories from the Asia–Pacific
The Asia–Pacific region is a vast geographic area with a loose definition — covering East Asia, Southeast Asia, and Oceania. It includes a variety of cultures and races and is home to both developed and developing countries. Depending on the definitions of the region, the gross domestic product (GDP) varies from $500 per capita in East Timor to $41,500 in Australia, and the populations climb from a mere 55,500 in Australian Samoa to a vast 1.3 billion in China (1).…
Shifting the Bioprocess Paradigm
The need for transformation is a powerful driving force in the biopharmaceutical industry. Opinions and predictions about the best way forward are plentiful. As drug developers seek to enhance productivity, reduce costs, and improve their return on investment in research and development, new ways of doing business are explored, evaluated, and acted upon — with varying degrees of success. Faced with intense pressure to evolve, the biopharmaceutical industry is smart to leverage approaches that have driven success in…
From The Editor
In one company I worked for, we were all given a year to participate in a project called “Budget Busters.†Each person and department was tasked with figuring out ways to save operating costs on all levels. Monthly cash awards were given to those who had made significant contributions to the program. Our mailroom manager created notepads for us from scrap paper. We began reusing manila folders, and our editorial department began using both sides of manuscript-tracking…
Monoclonal Antibody Manufacturing
Continuing the theme of this occasional series, we examine the role of manufacturing in the supply chain in terms of what is required to deliver affordable medicines to patients. The industry has debated the relevance of manufacturing costs in the overall big picture (1). Rising manufacturing costs as a proportion of the overall selling price coupled with increased competitive pressures creates a strong drive to reduce manufacturing costs. However, cost of goods (CoG) is not the only strategic…
Biosimilars in Development
The 2009 Biologics Price Competition and Innovation Act (BPCIA) provided the bioprocessing industry with the legislative pathway toward approval of biosimilars. US Food and Drug Administration information regarding how it will translate that legislation, however, had been limited until an August 2011 article finally provided some insight on how those guidances might actually play out (1). As expected, the agency appears to be implementing a science-driven approach, with sponsor companies needing to apply complementary orthogonal analytical methods to…
Australia
Australia is the only Asia–Pacific country that’s home to one of the world’s top-10 biotechnology companies (in revenue): CSL Limited, a maker of drugs, vaccines, antivenoms, blood products, and diagnostics. Many companies in the West consider this country a “gateway†to the Asia–Pacific region because of its relatively familiar culture, language, laws, and infrastructure. Indeed, Australia’s proximity to Singapore, Indonesia, Malaysia, and the rest of Asia compares favorably to the rest of the English-speaking world. For cell therapies…
China’s New Five-Year Plan
In October 2010, the Communist Party of China’s Central Committee approved its 12th Five-Year Plan for National Economic and Social Development (FYP) (2011–2015), which it ratified on 14 March 2011. During those five years, China will continue to focus on government-guided economic development, industry, and technology. The FYP outlines the government’s commitment toward reforming its economy and increasing its domestic consumption to decrease its dependence on exports for future growth of its gross domestic product (GDP). Other initiatives…